Racial diversity in clinical trials

Here’s a good-science headscratcher… The lack of racial diversity in clinical trials is well documented, even in trials for diseases that disproportionately affect ethnic minorities. To the extent Caucasians and ethnic minorities respond differently to drugs, this is bad science. But here’s the headscratcher: minorities more often present with comorbidities (e.g. stroke, hypertension, diabetes) that disqualify them from participation. It seems like these are the drug development and regulatory community’s options: (1) mandate greater minority participation into existing study protocols and likely slow down trials and approvals, (2) mandate greater minority participation and loosen exclusion criteria—making scientific conclusions fuzzier because of comorbidities, (3) change nothing and hope minorities aren’t harmed by the underrepresentation. Send your thoughts here. It’s not an easy topic.

SSU, SIV, FPI and KPIs – oh my

It isn’t often you find real data in conference presentations, but we did. Clinical trials get delayed, no news there. A 2017 report from CenterWatch showed each additional month in a phase III trial added a median expense of $671,000. There are lots of “fixes” out there, but if you’re involved in oncology trials, you’ll find an insightful site start-up presentation from Alicia Williams, Senior Project Manager at MedSource here. InsightCity reached out and asked her “What’s the one thing people should know?” Her response, “The key to improving site start-up time and efficiency lies in proper planning, information sharing, and transparency. Working collaboratively with our sponsors and sites and putting in the preparation to drive timelines leads to success.  It’s not easy, but it has a proven track record.”  Well said and thanks for not creating another conference presentation that looks like this.

Plaque attack

Treating Alzheimer’s has been a major issue for researchers, considering clinical trials that aim to treat the condition fail at a rate of 99.6 percent. Anything shown to remotely help will lead to big investments, as Biogen and Eisai learned on Thursday when they released positive results on their IND BAN2401. It’s not just a big deal because it could lead to a treatment, but also because it provides evidence we’ve figured out how the condition works. We think Alzheimer’s progresses from amyloid plaque accumulating between neurons, disrupting cell communication. The drug candidate doesn’t clean the plaque up, but it does clean up the cell clusters that form the plaque. Let’s hope this avenue of research provides more answers so we don’t end up spending $1 trillion on the condition by 2050.

Right to try, is it alright?

The FDA’s Compassionate Use program helps patients that seek access to medications still in the development pipeline. But legislation signed into law this week allows patients to completely bypass the regulatory agency should they so choose. The “Right to Try” bill gives patients access to investigational drugs with the permission of just their physician and the drug manufacturer. It also shields those drug companies from the legal risks involved. Critics, including the American Cancer Society, say the bill gives false hope to patients, and champion the current process of compassionate use and clinical trials. After all, the FDA approves 99% of compassionate use applications, and can even do approvals over the phone. When asked for comment, some formerly prominent musicians said “You gotta fight for your right… to paaaaaaaaarty.”

Watson answered the call

While Mr. Watson did answer Alexander Graham Bell’s first telephone call, what we’re talking about here is IBM’s Watson. The Mayo Clinic recently released results from a study whereby Watson “in the 11 months after implementation, there was on average an 80% increase in enrollment to Mayo’s systemic therapy clinical trials for breast cancer.”  That’s a huge increase given that ~3-5% of cancer patients participate in clinical trials. There’s also a Mayo Clinic radio (yes, there is such a thing) podcast for your listening enjoyment. For those in the clinical development industry, this could be a substantial step in using technology to increase clinical trial participation rates. DYK that IBM’s Watson is named after their first CEO, industrialist Thomas J. Watson? You do now and you’re now less likely to lose on Jeopardy.

I learn better from examples

We recently read one of the better reports on the use of digital technologies in the world of clinical development. Why is it better? Because Deloitte provides some actual case studies/ use cases for these technologies. In one example, a service provider, Science 37, used telemedicine to conduct a complete virtual Phase II study. We have no idea whether the trial will be part of an FDA submission, but cool nonetheless. Another interesting idea from Deloitte is using “Synthetic trial arms or master protocols to reduce the number of patients required to test investigational treatments. A synthetic trial arm uses data from previously completed trials or real-world evidence and is particularly useful in rare disease trials or when a placebo approach is not appropriate or ethical, as is often the case in oncology.” Love it. Speaking of synthetic, here’s a list of the worst synthetic fabrics to wear.

23andMe and clinical trials

Want some help with your 2018 weight loss resolution? 23andMe might be able to help. In December they announced the “Weight Loss Intervention Study” noting it will attempt to uncover more about why each of us responds differently to exercise and diet. If you’re a 23andMe customer, then maybe you can be 1 of 100,000 people they intend to recruit. This is not 23andMe’s first time conducting clinical trials. They have conducted them in Lupus and Parkinson’s. According to Dr. Liana Del Gobbo, “We’d like to better understand the genetic, demographic, psychosocial, and behavioral characteristics that predict weight loss success overall, and on different lifestyle interventions.” Cool, because anything’s better than this method of weight loss. And 23andMe is probably not done after raising $250M in September, just like InsightCity.